UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054473 |
|---|---|
| Receipt number | R000062204 |
| Scientific Title | Association between ICG R/K and biliary anatomy visualization by intraoperative fluorescene cholangiography |
| Date of disclosure of the study information | 2024/05/27 |
| Last modified on | 2025/01/04 22:45:29 |
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Basic information
Public title
Association between ICG R/K and biliary anatomy visualization by intraoperative fluorescene cholangiography
Acronym
Association between ICG R/K and biliary anatomy visualization
Scientific Title
Association between ICG R/K and biliary anatomy visualization by intraoperative fluorescene cholangiography
Scientific Title:Acronym
Association between ICG R/K and biliary anatomy visualization
Region
| Japan |
Condition
Condition
cholecystolithiasis, acute cholecystitis, chronic cholecystitis, gallbladder polyps
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between ICG K/R and intraoperative understanding of biliary anatomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brightness analysis of fluorescent biliary images for each ICG K/R score
Key secondary outcomes
1. brightness analysis of fluorescent biliary images for each ICG dose and administration time
2. brightness analysis of fluorescent biliary images for each surgical outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
administer 0.1 mg/kg of ICG 3 hours before surgery and perform an ICG testing
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient who undergo laparoscopic cholecystectomy for benign biliary disease
Key exclusion criteria
patient who have allergy of ICG and iodine
pregnant and breastfeeding women
patient who need to emergency operation
patient who are inappropriate for this study judged by doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shunya |
| Middle name | |
| Last name | Kiriyama |
Organization
Tajimi Municipal Hospital
Division name
Department of Surgery
Zip code
507-8511
Address
3-43 Maehata, Tajimi City, Gifu, Japan
TEL
0572-22-5211
kiri.shun84@gmail.com
Public contact
Name of contact person
| 1st name | Shunya |
| Middle name | |
| Last name | Kiriyama |
Organization
Tajimi Municipal Hospital
Division name
Department of Surgery
Zip code
507-8511
Address
3-43 Maehata, Tajimi City, Gifu, Japan
TEL
0572-22-5211
Homepage URL
kiri.shun84@gmail.com
Sponsor or person
Institute
Tajimi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Tajimi Municipal Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tajimi Municipal Hospital
Address
3-43 Maehata, Tajimi City, Gifu, Japan
Tel
0572-22-5211
kiri.shun84@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062204
